Phase Ⅲ Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg-positive Chronic Hepatitis B

Hansoh Pharma

Status and phase: Unknown; Phase 3

Conditions: Hepatitis B, Chronic

Treatments: Drug: Placebo to match PEG-Tα1; Drug: PEG-Tα1; Drug: Adefovir

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02366247

HS-20046-3

Details and patient eligibility

About

This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1 (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from Hansoh Pharmaceutical of China, in combination with adefovir in HBeAg-positive patients with chronic hepatitis B.

Full description

A total of 463 HBeAg-positive patients were recruited from 33 hospitals in China, and randomized to two groups. The combination group received PEG-Tα1 (3.2 mg/ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks. The control group received placebo and adefovir. The primary endpoint was the loss of HBeAg at 48 weeks. The secondary endpoints included 1) loss of hepatitis B virus (HBV) DNA, 2) HBeAg seroconversion and 3) alanine aminotransferase (ALT) normalization etc. at week 4, 12, 24, 36 and 48. The number of CD4＋and CD8＋T cells was also determined during 48 weeks.

Enrollment: 463 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic hepatitis B for more than 6 months, and didn't accept immunomodulating or anti-viral treatment within 6 months before the trial.
• ALT level > 2 × Upper Limit Normal (ULN).
• Serum bilirubin < 2 × ULN.
• Positive HBeAg and negative HBeAb.
• HBV-DNA between 1.00E＋05 IU/ml and 9.99E＋09 IU/ml.
• Informed Consent Form (ICF) signed.

Exclusion criteria

• Hepatitis A,C,D,E or HIV infection.
• Autoimmune hepatitis.
• Hepatic cirrhosis.
• Serum creatinine >1.5 × ULN or Ccr <50 ml/min, Haemoglobin <110g/L (male) or <100g/L (female), Platelet<80 E＋09/L, Serum albumin ≤ 35g/L, or Serum albumin/globulin (A/G) ≤0.9, Neutrophile granulocyte <1.0 E＋09/L, Prothrombin time>ULN＋3 seconds, Cholinesterase<4000U/L.
• Hepatitic carcinoma or Alpha Fetal Protein (AFP) >100ng/ml .
• Patients with other severe diseases combined, which could affect the therapy.
• Patients accepted other clinical trial within 6 months before the first administrated.
• Thymosin allergy.
• Pregnant or breast feeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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463 participants in 2 patient groups, including a placebo group

PEG-Tα1

Experimental group

Description:

PEG-Tα1 (3.2 mg/ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks

Treatment:

Drug: Adefovir

Drug: PEG-Tα1

Placebo to match PEG-Tα1

Placebo Comparator group

Description:

PEG-Tα1 placebo (1ml, once a week, taken subcutaneously) and adefovir (10 mg, once daily, taken orally) for 48 weeks

Treatment:

Drug: Adefovir

Drug: Placebo to match PEG-Tα1